ARYx reports positive results from Phase IIb constipation trial

The clinical trial was a Phase IIb, randomized, placebo-controlled study of ATI-7505 in patients with chronic idiopathic constipation conducted at 42 trial sites in five countries. Patients were treated for four weeks and the primary efficacy endpoint was the improvement in the total number of spontaneous bowel movements (SBM) during the first seven days after randomization compared to placebo.

Patients were randomized to either placebo or doses of ATI-7505 of 20mg twice a day (bid), 40mg bid, 80mg bid, or 120mg bid. Randomization was balanced amongst all treatment arms. SBM was defined as a bowel movement occurring without the need for a laxative or enema within the preceding 24 hours. Safety assessments were conducted on every patient enrolled.

Utilizing the original statistical analysis plan for the full study, statistical significance (p=0.0031) was achieved at the 80mg bid dose with an increase of a mean of 3.32 SBMs in the first week compared to baseline. In the placebo group, this increase was only 0.31 SBMs

A preliminary analysis of the overall responder rate indicates ATI-7505 maintained its positive effect over the full four-week treatment period. In addition, time-to-first SBM using a Kaplan-Meier analysis suggests that many patients on ATI-7505, unlike placebo, have their first SBM following the first dose of the drug and this effect was observed at all doses tested. The 80mg bid dose was very well tolerated and there were no reports of diarrhea, nausea or vomiting.